Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof James Malone-Lee


Contact details

University College London
Whittington Hospital Campus
N19 5LW
United Kingdom

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

A randomised, double-blind, placebo-controlled study of AIMSPRO® in secondary progressive multiple sclerosis (MS)


Study hypothesis

That AIMSPRO® will increase the average voided volume in patients with secondary progressive multiple sclerosis and overactive bladder symptoms.

More details on this trial can be found on the UK MS Society Clinical Trials Database at:

Ethics approval

National Research Ethics Committee, National Hospital for Neurology and Neurosurgery, University College London Hospitals Foundation NHS Trust

Study design

Treatment, parallel-assignment, double-blind (subject, caregiver, investigator, outcomes assessor), randomised, crossover, placebo-controlled, safety/efficacy trial

Primary study design


Secondary study design

Randomised cross over trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Bladder dysfunction in patients with secondary progressive multiple sclerosis


AIMSPRO® (manufactured by Sypharma Pty Ltd, Australia) vs placebo (cross-over trial).

1.0 ml twice weekly of AIMSPRO®/placebo for 4 weeks, injected subcutaneously, followed by a 6-week washout period and then the crossover medication for a further 4-week period.

Intervention type



Not Applicable

Drug names


Primary outcome measure

To determine whether the regular administration of AIMSPRO® improves bladder dysfunction, manifest as an increase in average voided volume

Secondary outcome measures

1. To determine whether the regular administration of AIMSPRO® improves other manifestations of bladder dysfunction including frequency, urgency and incontinence episodes
2. To determine whether regular administration of AIMSPRO® improves general disability
3. To verify findings from a peer-reviewed uncontrolled observational study related to possible changes in colour vision in MS patients taking AIMSPRO®

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Male and female patients aged 18 years or older
2. Men and women of childbearing potential must use adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last injection of AIMSPRO®
3. Clinically definite secondary progressive multiple sclerosis
4. Ambulant, walking aids allowed
5. No more than one relapse within the last 12 months and no relapse within the last 6 months
6. Urinary frequency of 8 times per 24 hours
7. Urinary urgency with or without urge incontinence
8. Magnetic resonance imaging (MRI) brain or spinal cord abnormalities consistent with the diagnosis of MS
9. Haemoglobin >9.5 g/dL
10. White blood cells (WBC) >3.5 x 10^9/L
11. Neutrophils >1.5 x 10^9/L
12. Platelets >100 x 10^9/L
13. Baseline AST, alkaline phosphatase, thyroid function, serum electrophoresis levels must be within their normal ranges
14. Able to adhere to the study visit schedule and other protocol requirements
15. Capable of giving written informed consent. Consent must be obtained prior to any screening procedures.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Acute symptomatic urinary infection
2. Taking DDAVP® for control of nocturia
3. Taking antimuscarinic agents for the control of overactive bladder symptoms
4. Full-time wheelchair user
5. History of immunosuppressant drug therapy of any kind in the last 3 months
6. Relapse within the last 6 months
7. No clear progression of disability in the last 12 months
8. Co-existent medical condition precluding participation, including any history of severe allergic reaction
9. Pregnant or lactating women and women who are planning pregnancy within 12 months of screening (i.e., approximately 6 months following last injection)
10. Receipt of any investigational drug within 30 days prior to screening or within 5 half-lives of the investigational agent, whichever is longer
11. Treatment with any therapeutic agent targeted at reducing tumour necrosis factor (TNF) (e.g., infliximab, pentoxifylline, thalidomide, etanercept, etc) within 3 months of screening
12. Previous administration of AIMSPRO®
13. Ongoing corticosteroid therapy or any corticosteroids within the previous 3 months
14. Known allergy to animal proteins
15. Known history of tuberculosis
16. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections such as acute upper respiratory tract infection or simple urinary tract infection should be followed to their conclusion or treated, as appropriate, prior to inclusion
17. Opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, Aspergillosis, histoplasmosis or atypical mycobacterium infection, etc, within the previous 6 months
18. Established malignant disease or renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease
19. A significant other neurological disorder
20. Presence of a transplanted organ, with the exception of a corneal transplant >3 months prior to screening
21. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly
22. Known recent clinically significant substance abuse (drug or alcohol)
23. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period
24. Investigational drugs or drugs targeted at reducing TNF - these are not allowed during participation in the study
25. Patients will not be permitted to receive immunosuppressive treatment during this study. The exception will be where a patient's treating neurologist determines that a course of steroid therapy, oral or intravenous, is required in view of a sufficiently disabling relapse of MS
26. Immunosuppressive therapy within the month prior to entry into the study
27. Taking the licensed anticonvulsant medication lamotrigine or the anti-arrhythmic drug flecainide, both of which are potent sodium channel blocking agents
28. Unable to fill in the criteria related to bladder dysfunction status
29. Unable to give written informed consent

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University College London
N19 5LW
United Kingdom

Sponsor information


Daval International Ltd (UK)

Sponsor details

4a Gildredge Street
BN21 4RL
United Kingdom
+44 (0)845 130 3014

Sponsor type




Funder type


Funder name

Daval International Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/03/2017: No publications found, verifying study status with principal investigator. 18/08/2011: The overall trial end date has again been refined, and the following end dates are now accurate: Double-blind phase end date: May 2011 Open-label phase: March 2012 The previous overall trial end date was 01/10/2011 27/10/2010: The overall trial end date has been refined, and the following end dates are now accurate: Double-blind phase end date: February 2011 Open-label phase: October 2011 The previous overall trial end date was 01/11/2009